AIT-082 Phase 1B Study

This study has been completed.

First Received: October 29, 1999 Last Updated: June 23, 2005 History of Changes

Sponsored by:	National Institute on Aging (NIA)
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00000180

Purpose

AIT-082 is a novel small molecule that crosses the blood-brain barrier to enhance nerve function by increasing levels of neurotrophic growth factors and encouraging nerve sprouting in the brain. Preclinical studies in animals have shown that AIT-082 improves memory in aged animals and in animals with neurological deficits.

This study was a double-blind placebo-controlled safety study that was designed to study whether AIT-082 may delay age-related mental decline. Eight healthy older volunteers at two clinical sites were given single, weekly, rising doses of AIT-082 or placebo for 5 weeks; were tested for side effects and absorption; and underwent a battery of neuropsychological memory tests, including word and number recall tests.

Condition	Intervention	Phase
Memory Disorders	Drug: AIT-082	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control

Resource links provided by NLM:

MedlinePlus related topics: Memory

Drug Information available for: Ait 082

U.S. FDA Resources

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000180

Locations

United States, California
University of California, San Diego
San Diego, California, United States, 92093-0949
United States, Indiana
Indiana University Alzheimer's Center
Indianapolis, Indiana, United States, 46202
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109-0322
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110

Sponsors and Collaborators

National Institute on Aging (NIA)

Investigators

Principal Investigator:

Michael Grundman, M.D., M.P.H.

University of California, San Diego

More Information

Publications:

Grundman M, Capparelli E, Kim HT, Morris JC, Farlow M, Rubin EH, Heidebrink J, Hake A, Ho G, Schultz AN, Schafer K, Houston W, Thomas R, Thal LJ; Alzheimer's Disease Cooperative Study. A multicenter, randomized, placebo controlled, multiple-dose, safety and pharmacokinetic study of AIT-082 (Neotrofin) in mild Alzheimer's disease patients. Life Sci. 2003 Jun 20;73(5):539-53.

Study ID Numbers:	IA0008, 3U01AG10483-08S2
Study First Received:	October 29, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000180 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

Memory
Mild cognitive impairment
Nerve growth factors

Study placed in the following topic categories:

Signs and Symptoms
Mitogens
Neurologic Manifestations
Neurobehavioral Manifestations
Memory Disorders

Additional relevant MeSH terms:

Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations
Neurobehavioral Manifestations
Memory Disorders

ClinicalTrials.gov processed this record on July 02, 2009